BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH TX2 DISSECTION ENDOVASCULAR GRAFT TAPERED COMPONENT

    MDR report key: 11663434 · Received April 14, 2021

    Report

    Report Number
    3002808486-2021-01094
    Event Type
    Injury
    Date Received
    April 14, 2021
    Date of Event
    January 15, 2021
    Report Date
    September 3, 2021
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002242569
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF# (B)(4). INVESTIGATION IS STILL IN PROGRESS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Additional Manufacturer Narrative · 1

    MANUFACTURER REF# (B)(4). SIMILAR TO DEVICE MARKETED UNDER PMA/510(K): P180001. INVESTIGATION IS STILL IN PROGRESS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: ON (B)(6) 2020 DURING THE INDEX PROCEDURE, A ZDEG-PT-32-202-PF (LOT# E3954754) WAS IMPLANTED WITHOUT DIFFICULTY. THE REPORTED DEGREE OF OVERSIZING WAS 10%. A MOLDING BALLOON WAS NOT USED DURING THE PROCEDURE AND NO OTHER DEVICES WERE PLACED. PRIMARY INDICATION FOR IMPLANT WAS AN AORTIC DISSECTION. THE PRIMARY TEAR WAS DISTAL TO THE LEFT SUBCLAVIAN ARTERY. THE PROXIMAL LOCATION OF THE DISSECTION WAS WITHIN THE LEFT SUBCLAVIAN ARTERY AND THE DISTAL LOCATION WAS THE INFRARENAL AORTA. THE PROXIMAL SEAL ZONE HAD MILD TORTUOSITY AND MODERATE CALCIFICATION WITH NO OCCLUSIVE DISEASE OR THROMBUS. THE DEVICE WAS IMPLANTED BELOW THE LEFT SUBCLAVIAN ARTERY. THE DEVICE WAS PATENT WITHOUT DEVICE INTEGRITY ISSUES AT THE END OF THE PROCEDURE. THE PATIENT WAS DISCHARGED ON (B)(6) 2020. A (B)(6) 2020 CT REVEALED THE DEVICE WAS PATENT AND WITHOUT DEVICE INTEGRITY ISSUES. ON (B)(6) 2021 (56 DAYS POST-PROCEDURE) A FOLLOW-UP CT REVEALED THE DEVICE WAS PATENT WITH NO MIGRATION OR DEVICE INTEGRITY ISSUES. A PSEUDOANEURYSM AT THE DISTAL LANDING ZONE. NO TREATMENT HAS BEEN REPORTED AT THIS TIME. THE CLINICAL STUDY SITE REPORTS THE PSEUDOANEURYSM IS ¿DUE TO THE IMPLANTATION OF THE STUDY DEVICE¿ AND ALSO REPORTS THAT ¿ABDOMINAL WALL ABNORMALITIES¿ MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE SITE RESPONDED ¿NO¿ TO THE QUESTION ¿DID THE EVENT OCCUR DUE TO A DEVICE DEFICIENCY¿. PATIENT OUTCOME: NO INTERVENTION HAS BEEN PLANNED. THE PATIENT REMAINS IN THE STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564996 ZENITH TX2 DISSECTION ENDOVASCULAR GRAFT TAPERED COMPONENT MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE E3954754 10827002242569

    Patients

    Seq Age Sex Outcome Treatment
    1